TRUFILL PUSHABLE COILS

Additional Manufacturer Narrative

THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT #1058196-2010-00049. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem

THE PROCEDURE WAS COIL EMBOLIZATION FOR D-AVF (DURAL ARTERIOVENOUS FISTULA), 2 OF THE TRUFILL ORBIT COILS 633-320X (13314673, COMPLAINT PRODUCT X2) WERE USED IN THE PROCEDURE. FIRST COIL WAS INSERTED IN THE MICROCATHETER (DETAILS UNK) FOR EMBOLIZATION, WHILE THE COIL WAS PUSHED IT WAS STUCK IN THE MICRO CATHETER (EXCELSIOR, BSJ) AND COULD NOT BE ADVANCED ANY FURTHER. THE COIL WAS REMOVED SUCCESSFULLY WITH THE MICRO CATHETER AS A UNIT. SECOND COIL (SAME CAT & LOT) WAS INSERTED BUT THE SAME THING HAPPENED. EVENTUALLY, ANOTHER COIL (SAME SIZE, LOT UNK) WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PT INJURY. THERE WAS NO ADVERSE EVENT AND THE PT IS IN STABLE CONDITION. THE PT'S GENDER AND AGE WERE UNK. NO CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS UNK. IT WAS ALSO REPORTED THAT ALL IFU GUIDELINES WERE FOLLOWED FOR DELIVERY OF ALL THE PRODUCTS. DURING THE EVENT, THERE WERE NO CONTRIBUTING FACTORS TO THE COILS GETTING STUCK IN THE MICROCATHETERS. HOWEVER, A CONSTANT FLUSH WAS MAINTAINED IN THE MICROCATHETER.